SAN DIEGO - April 16, 2013 (Investorideas.com newswire) - Aethlon Medical, Inc. (
OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
As disclosed in yesterday's SEC form 8-K submission, we entered
into a subcontract agreement with Battelle Memorial Institute (Battelle)
to provide services underlying a $22.8 million prime contract that was
recently awarded to Battelle by the Defense Advanced Research Projects
Agency (DARPA). The objective of this contract program is to integrate
component technologies developed in DARPA's Dialysis Like Therapeutics
(DLT) program into medical device that would save military and civilian
lives by effectively treating sepsis. Beyond expanding our opportunity
in the DLT program, we are honored to have the opportunity to work with
Battelle (the world's largest independent research and development
organization) on this endeavor.
We were previously awarded a $6.8 million contract from DARPA to
develop two technology components in the DLT program. Our first
component objective has been the development of a therapeutic cartridge
that selectively eliminates septic precursors, bacterial toxins, viral
pathogens, and disease enhancing exosomes from the entire circulatory
system. Our second component objective is the creation of a blood
processing system that would allow for the delivery of various
extracorporeal therapies without the need to administer systemic
anticoagulants. We are now in year two of this five-year contract and
have achieved eleven DLT milestone objectives to date.
On a different front, I am pleased to share that we resubmitted an
Investigational Device Exemption (IDE) to the U.S. Food and Drug
Administration (FDA) on March 25th. Our goal is to receive permission
to initiate a clinical feasibility study of Hepatitis-C (HCV) infected
individuals who would be enrolled to receive Hemopurifier® therapy. An
update on this effort should be available in the coming weeks. As
reported from clinical studies conducted overseas, a three-treatment
Hemopurifier® protocol administered in combination with interferon-based
standard-of-care resulted in undetectable HCV in as little at seven
days in hard to treat genotype-1 patients.
The proven ability of our Hemopurifier® to capture a broad-spectrum of viral pathogens (see:
www.aethlonmedical.com/assets/001/5040.pdf)
might also set the stage for us to revisit opportunities related to the
treatment of drug and vaccine resistant agents. While funding for many
healthcare programs has been cut as a result of sequestration, I am
pleased to report that the funding spigot for countermeasures against
bioterror and pandemic threats has been turned back on. Last month, The
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of
2013 was signed into law by President Obama. The law reauthorizes
provisions of the Project Bioshield Act of 2004 and extends the mandate
of the Biomedical Advanced Research and Development Authority (BARDA) to
support medical countermeasure development for biothreat agents for
possible inclusion in the U.S. Strategic National Stockpile. PAHPRA also
enhances the authority of the FDA to support rapid responses to public
health emergencies by clarifying that even before an event occurs, FDA
may issue an emergency use authorization to allow emergency use of
certain products as medical countermeasures. The Congressional Budget
Office estimates that $11 billion will be spent on PAHPRA between fiscal
years 2014 to 2018.
The scope of PAHPRA 2013 legislation includes the support of
treatment countermeasures against bioterror threats created by man as
well as naturally emerging threats, such as the H7N9 strain of bird flu
that has triggered 13 reported deaths in China. Health officials are
concerned that humans may have no natural immunity to H7N9, as it had
not been previously detected in humans. Additionally, clinical trials of
candidate vaccines against other H7 viral strains have not been able to
induce an immune response, even when administered in very large doses.
And, unlike the recent H5N1 bird flu outbreak, the H7N9 strain does not
seem does not seem to cause significant illness in birds themselves.
As a result, tracking and containing the spread of the virus could be an
immense challenge. The good news is that H7N9 has not evolved to
spread easily within human populations. However, it establishes a
compelling rationale for why emerging non-vaccine technologies such as
our Hemopurifier® need to be tested. Previously, the Hemopurifier® was
validated to capture the H5N1 bird flu virus, the H1N1 swine flu virus
and the reconstructed Spanish flu virus of 1918, which triggered the
deaths of approximately 50 million people worldwide.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address
unmet medical needs in cancer, infectious disease, and other
life-threatening conditions. Our Aethlon ADAPT™ System is a
revenue-stage technology platform that provides the basis for a new
class of devices the rapid, yet selective removal of disease promoting
particles from the entire circulatory system. At present, The Aethlon
ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address
infectious disease and cancer, and a medical device being developed
under a 5-year contract with Defense Advanced Research Projects Agency
(DARPA) to reduce the incidence of sepsis in combat-injured soldiers.
For more information, please visit
www.aethlonmedical.com.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that
selectively targets the rapid clearance of infectious viral pathogens
and immunosuppressive proteins from the entire circulatory system. In
the treatment of Hepatitis C virus (HCV), human studies have
demonstrated that Hemopurifier® therapy may improve immediate, rapid and
sustained virologic response rates when administered in the first few
days of standard-of-care drug therapy. In addition to accelerating viral
load depletion, post-treatment analysis of the Hemopurifier® has
documented the capture of up to 300 billion HCV copies of HCV during a
single six-hour treatment. Access to Hemopurifier® therapy is available
on a compassionate-use basis through the Medanta Medicity Institute
(Medicity), a leading center for medical tourism in India. The Medicity
is offering treatment access to infected individuals who previously
failed or subsequently relapsed standard-of-care drug regimens. The
Hemopurifier® is also being offered as a salvage therapy to infected
individuals who suffer a viral breakthrough during standard-of-care
therapy. U.S. studies of the Hemopurifier® are currently pending
approval of an IDE submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of
infectious viral pathogens, the Hemopurifier® has been discovered to
capture tumor-derived exosomes underlying several forms of cancer.
Tumor-derived exosomes have recently emerged to be a vital therapeutic
target in cancer care. These microvesicular particles suppress the
immune response in cancer patients through apoptosis of immune cells and
their quantity in circulation correlates directly with disease
progression. Beyond possessing immunosuppressive properties,
tumor-derived exosomes facilitate tumor growth, metastasis, and the
development of drug resistance. By addressing this unmet medical need,
the Hemopurifier® is positioned as an adjunct to improve established
cancer treatment regimens.
Certain statements herein may be forward-looking and involve risks
and uncertainties. Such forward-looking statements involve assumptions,
known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of Aethlon
Medical, Inc. to be materially different from any future results,
performance, or achievements expressed or implied by the forward-looking
statements. Such potential risks and uncertainties include, without
limitation, that the company can successfully protect its intellectual
property, that removal of exosomes from the human body will impact or
lead to successful treatment of cancer, or that exosomes are the cause
of tumor growth and progression, that the FDA will not approve the
initiation of the Company's clinical programs or provide market
clearance of the company's products, future human studies whether
revenue or non-revenue generating of the Aethlon ADAPT™ system or the
Aethlon Hemopurifier® as an adjunct therapy to improve patient
responsiveness to established cancer or hepatitis C therapies or as a
standalone cancer or hepatitis C therapy, the Company's ability to raise
capital when needed, the Company's ability to complete the development
of its planned products, the Company's ability to manufacture its
products either internally or through outside companies and provide its
services, the impact of government regulations, patent protection on the
Company's proprietary technology, product liability exposure,
uncertainty of market acceptance, competition, technological change, and
other risk factors. In such instances, actual results could differ
materially as a result of a variety of factors, including the risks
associated with the effect of changing economic conditions and other
risk factors detailed in the Company's Securities and Exchange
Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of
new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com Newswire
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About MDHI
The Company recently announced an update with details about its
growth rate and a contract signed with a diversified national insurer
where Medical Alarm Concepts will become a provider of personal medical
alarms.
More info on AEMD: